跳至主要内容
临床试验/CTRI/2025/09/094537
CTRI/2025/09/094537尚未招募4 期

EFFECT OF INTRAOPERATIVE 2 PERCENTAGE LIGNOCAINE INFUSION ON POSTOPERATIVE FENTANYL CONSUMPTION IN RENAL TRANSPLANT RECIPIENTS: A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL

Sir Ganga Ram Hospital, New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Cumulative fentanyl consumption

研究概览

简要总结

Chronic kidney disease is defined as decreased glomerular filtration rate (GFR) less than 60ml/min/1.73m2 for three months or more. The best available therapeutic option for the patient’s long-term survival is renal transplantation. Renal transplantation is associated with moderate to severe postoperative pain requiring effective pain management. Perioperative 2% lignocaine infusion has been used for post operative pain relief, however very little evidence is available for its use in renal transplant patients.

The study aims to evaluate the impact of 2% lignocaine infusion on reducing fentanyl consumption in this patient population in the postoperative period. By reducing opioid consumption, lignocaine infusion may provide a useful adjunct to standard anaesthesia and pain management, leading to improved patient outcomes.

In this double-blind randomized trial, we will enrol 50 patients, 25 patients in two groups scheduled for elective renal transplant surgery. Participants will be randomly assigned into two groups: Group A will be receiving 2% lignocaine 1.5mg/kg bolus dose at induction followed by infusion 1.5mg/kg/hr till renal reperfusion, Group B will be receiving normal saline at the same rate and same volume in patient undergoing renal transplant surgery. Post- surgery, patients will receive patient-controlled analgesia (PCA) with fentanyl and cumulative fentanyl consumption will be recorded within 24 hours period.

This study hypothesizes that 2% lignocaine infusion will decrease fentanyl consumption by 30%, post operatively in renal transplant recipients.

If proven effective, these results could justify the use of lignocaine as an adjunct to renal transplant protocols, ultimately enhancing patient safety and improving postoperative recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Males or Females
  • Age: 18-65 years.

排除标准

  • Failure to obtain Consent
  • History of lignocaine sensitivity
  • LVEF less than 50%
  • ASA IV (American Society of Anaesthesiology grade IV).

结局指标

主要结局

Cumulative fentanyl consumption

时间窗: postoperatively first 24 hours

次要结局

  • 1. Intraoperative hemodynamic parameters.(2. Adverse effects like nausea and vomiting within 2 hours, postoperative)

研究者

发起方
Sir Ganga Ram Hospital, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rashmi Jain

Sir Ganga Ram Hospital, New Delhi

研究点 (1)

Loading locations...

相似试验